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Study of Efficacy and Safety of JDQ443 Single-agent as First-line Treatment for Patients With Locally Advanced or Metastatic KRAS G12C- Mutated Non-small Cell Lung Cancer With a PD-L1 Expression < 1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation.

NCT ID: NCT05445843

Last Updated: 2025-11-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-06

Study Completion Date

2027-11-30

Brief Summary

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This study aims to evaluate the antitumor activity and safety of JDQ443 single-agent as first-line treatment for participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbor a KRAS G12C mutation and have a PD-L1 expression \< 1% (cohort A) or a PD-L1 expression ≥ 1% and an STK11 co-mutation (cohort B).

Detailed Description

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This is a non-randomized, open-label, single-arm, multicenter, phase II study evaluating the antitumor activity and safety of JDQ443 single-agent as first-line treatment for participants with locally advanced or metastatic KRAS G12C-mutated NSCLC.

The study will have 2 non-comparative cohorts that will recruit participants in parallel according to the following characteristics:

* Cohort A: participants whose tumors harbor a KRAS G12C mutation and a PD-L1 expression \< 1%, regardless of STK11 mutation status.
* Cohort B: participants whose tumors harbor a KRAS G12C mutation, a PD-L1 expression ≥ 1% and an STK11 co-mutation.

The study treatment begins on Cycle 1 Day 1 (C1D1) with the first administration of JDQ443. One treatment cycle consists of 21 (±3) days.

Study completion is defined as the earliest occurrence of one of the following:

* The last participant completes last study visit (and the assessments associated with this visit have been documented and followed-up appropriately by the Investigator), dies, withdraws consent, or is lost to follow-up, whichever comes first.\]
* In the event of an early study termination decision, the date of that decision.
* Another clinical study becomes available that can continue to provide JDQ443 to study participants and all participants with ongoing treatment are transferred to that clinical study.

Conditions

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Locally Advanced or Metastatic KRAS G12C-mutated NSCLC With a PD-L1 Expression <1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation

Keywords

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Lung cancer NSCLC KRAS G12C STK11 PD-L1 JDQ443

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort A- PD-L1<1%

Participants whose tumors harbor a KRAS G12C mutation and a PD-L1 expression \< 1%, regardless of STK11 mutation status.

Group Type EXPERIMENTAL

JDQ443

Intervention Type DRUG

JDQ443 per os (PO) 200 mg twice a day continuously

Cohort B- PD-L1≥ 1% and STK11 mutation

Participants whose tumors harbor a KRAS G12C mutation, a PD-L1 expression ≥ 1% and an STK11 co-mutation.

Group Type EXPERIMENTAL

JDQ443

Intervention Type DRUG

JDQ443 per os (PO) 200 mg twice a day continuously

Interventions

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JDQ443

JDQ443 per os (PO) 200 mg twice a day continuously

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed locally advanced (stage IIIb/IIIc not eligible for definitive chemoradiation or surgical resection with curative intent) or metastatic (stage IV) NSCLC without previous systemic treatment for metastatic disease. Prior (neo)adjuvant treatment with chemotherapy and/or immunotherapy, or prior radiotherapy administered sequentially or concomitantly with chemotherapy and/or immunotherapy for localized or locally advanced disease are accepted if the time between therapy completion and enrollment is \> 12 months.
* Presence of a KRAS G12C mutation (all participants) and:

* Cohort A: PD-L1 expression \< 1%, regardless of STK11 mutation status
* Cohort B: PD-L1 expression ≥ 1% and an STK11 co-mutation
* At least one measurable lesion per RECIST 1.1.
* ECOG performance status ≤ 1.
* Participants capable of swallowing study medication.

Exclusion Criteria

* Participants whose tumors harbor an EGFR-sensitizing mutation and/or ALK rearrangement by local laboratory testing. Participants with other known druggable alterations will be excluded, if required by local guidelines
* Previous use of a KRAS G12C inhibitor or previous systemic treatment for metastatic NSCLC.
* A medical condition that results in increased photosensitivity (i.e., solar urticaria, lupus erythematosus, etc.).
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Participants who are taking a prohibited medication (strong CYP3A inducers) that cannot be discontinued at least seven days prior to the first dose of study treatment and for the duration of the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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The Brown University Oncology Group

Providence, Rhode Island, United States

Site Status

Novartis Investigative Site

Pilar, Buenos Aires, Argentina

Site Status

Novartis Investigative Site

Buenos Aires, , Argentina

Site Status

Novartis Investigative Site

Córdoba, , Argentina

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Novartis Investigative Site

Córdoba, , Argentina

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Novartis Investigative Site

Feldkirch, , Austria

Site Status

Novartis Investigative Site

Wels, , Austria

Site Status

Novartis Investigative Site

Sint-Niklaas, Oost Vlaanderen, Belgium

Site Status

Novartis Investigative Site

Roeselare, West-Vlaanderen, Belgium

Site Status

Novartis Investigative Site

Salvador, Estado de Bahia, Brazil

Site Status

Novartis Investigative Site

Belo Horizonte, , Brazil

Site Status

Novartis Investigative Site

Rio de Janeiro, , Brazil

Site Status

Novartis Investigative Site

Wuhan, Hubei, China

Site Status

Novartis Investigative Site

Changsha, Hunan, China

Site Status

Novartis Investigative Site

Beijing, , China

Site Status

Novartis Investigative Site

Marseille, Bouches Du Rhone, France

Site Status

Novartis Investigative Site

Bron, , France

Site Status

Novartis Investigative Site

Montpellier, , France

Site Status

Novartis Investigative Site

Saint-Herblain, , France

Site Status

Novartis Investigative Site

Strasbourg, , France

Site Status

Novartis Investigative Site

Kempten (Allgäu), Bavaria, Germany

Site Status

Novartis Investigative Site

Halle, Saxony-Anhalt, Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Oldenburg, , Germany

Site Status

Novartis Investigative Site

Tübingen, , Germany

Site Status

Novartis Investigative Site

Athens, , Greece

Site Status

Novartis Investigative Site

Mátraháza, , Hungary

Site Status

Novartis Investigative Site

Thellakom Kottayam, Kerala, India

Site Status

Novartis Investigative Site

Varanasi, Uttar Pradesh, India

Site Status

Novartis Investigative Site

Bari, BA, Italy

Site Status

Novartis Investigative Site

Rozzano, MI, Italy

Site Status

Novartis Investigative Site

Roma, RM, Italy

Site Status

Novartis Investigative Site

Orbassano, TO, Italy

Site Status

Novartis Investigative Site

George Town, Pulau Pinang, Malaysia

Site Status

Novartis Investigative Site

Kuching, Sarawak, Malaysia

Site Status

Novartis Investigative Site

Breda, North Brabant, Netherlands

Site Status

Novartis Investigative Site

Leeuwarden, Provincie Friesland, Netherlands

Site Status

Novartis Investigative Site

Porto, , Portugal

Site Status

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Novartis Investigative Site

Bangkok, , Thailand

Site Status

Novartis Investigative Site

Istanbul, Bagcilar, Turkey (Türkiye)

Site Status

Novartis Investigative Site

Diyarbakır, Sur, Turkey (Türkiye)

Site Status

Novartis Investigative Site

Ankara, Yenimahalle, Turkey (Türkiye)

Site Status

Novartis Investigative Site

Torquay, , United Kingdom

Site Status

Countries

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Bulgaria Singapore United States Argentina Austria Belgium Brazil China France Germany Greece Hungary India Italy Malaysia Netherlands Portugal Spain Thailand Turkey (Türkiye) United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2024-511708-18-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CJDQ443B12201

Identifier Type: -

Identifier Source: org_study_id